NCT02402478

Brief Summary

The purpose of this study is to advance research through collaboration, 4C was established in the United Kingdom (UK) in 2009 as a resource in which deoxyribonucleic acid (DNA) and biomarker samples were obtained at time of presentation with chest pain linked to detailed phenotypic data obtained from electronic health records and participant self-completed questionnaires. The investigators sought to explore and assess the current potential of setting up a comparable consented research platform by collecting DNA samples and to quantify the extent to which diverse NHS hospital information systems are accessible for extracting secondary care data (structured and unstructured) for research purposes at scale.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,345

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2009

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 30, 2015

Completed
Last Updated

March 30, 2015

Status Verified

March 1, 2015

Enrollment Period

4.5 years

First QC Date

March 18, 2015

Last Update Submit

March 24, 2015

Conditions

Coronary Heart Disease

Keywords

Clinical CohortElectronic Health RecordsPrognosisStable Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular events

    The primary endpoint is a pre-specified composite of cardiovascular mortality, non-fatal AMI, non-fatal stroke and peripheral arterial disease.

    Up to 30 years

Secondary Outcomes (1)

  • Quality of life

    Up to 30 years

Study Arms (1)

Stable coronary artery disease

Patients with chest pain

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients undergoing investigation for new-onset, non-acute chest pain at four UK NHS hospitals.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

DNA, plasma and serum

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Harry Hemingway, Prof

    Farr Institute of Health Informatics Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2015

First Posted

March 30, 2015

Study Start

July 1, 2009

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

March 30, 2015

Record last verified: 2015-03